BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABL80 FLEX CO-OX ANALYZER

    MDR report key: 1762678 · Received June 25, 2010

    Report

    Report Number
    2027541-2010-00003
    Event Type
    Malfunction
    Date Received
    June 25, 2010
    Date of Event
    May 27, 2010
    Report Date
    May 28, 2010
    Manufacturer
    SENDX MEDICAL, INC.
    Product Code
    CHL
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATA LOGS FROM THE ANALYZER IN QUESTION WERE REVIEWED. THE ANALYZER APPEARS TO HAVE BEEN FUNCTIONING WELL AND WITHIN SPECIFICATIONS PRIOR TO THE ISSUE BEING DISCOVERED. PRELIMINARY CONCLUSIONS REGARDING THE UNUSUAL PHENOMENON ON SENSOR CASSETTE 1/N 48368 ARE POSSIBLE SAMPLE CONTAMINATION (AN INTERFERING SUBSTANCE SUCH AS CHEMOTHERAPY AGENTS). AN EXAMINATION OF THE RETURNED SENSOR CASSETTE DID NOT REVEAL SENSOR CASSETTE MEMBRANE DEFECTS. NO DEFINITIVE ROOT CAUSE FOR THE ISSUE WAS IDENTIFIED. IT IS POSSIBLE THAT THE ISSUE WAS CAUSED BY INTERFERENCE OR A MEMBRANE DEFECT. THE INITIAL REPORTER INDICATED THE FOLLOWING: THEY USED A VARIETY OF PATIENT SAMPLES. FOR HIPAA PRIVACY, THE PATIENT SAMPLES THAT WERE USED WERE IDENTIFIED BY USING A SEQUENTIAL INTERNAL LAB NUMBER THAT REPEATS EACH DAY. (B)(6). THE SAMPLES CAME FROM A VARIETY OF UNITS (ER, OR, ICU, PEDS, INPT. UNITS). IT IS POSSIBLE THAT ONE OF THESE COULD HAVE BEEN FROM A CANCER PATIENT ON CHEMOTHERAPY. IT WOULD BE DIFFICULT TO GO BACK AND POSITIVELY DETERMINE PATIENT ID AND TRACK WHAT TYPE OF MEDICATIONS THEY WERE ON. INTERFERING SUBSTANCES INCLUDING CHEMOTHERAPY AGENTS, ARE LISTED IN THE OPERATOR'S MANUAL FOR THE DEVICE. DEVICE LABELING (LIMITATIONS OF USE IN THE OPERATOR'S MANUAL) STATES THAT THE VALIDITY OF THE TEST RESULTS FROM THIS INSTRUMENT MUST BE CAREFULLY EXAMINED BY A CLINICIAN AND RELATED TO THE PATIENT'S CLINICAL CONDITION, BEFORE ANY CLINICAL DECISION IS TAKEN ON THE BASIS OF THE TEST RESULTS. THERE WAS NO PATIENT INJURY WITH THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2010, A HOSPITAL EMPLOYEE REPORTED A PROBLEM WHERE GLUCOSE WAS REPORTED AS 34 MG/DL ON THE ABL 80 CO-OX ANALYZER BUT ON A SIEMENS INSTRUMENT, THE GLUCOSE WAS 102 MG/DL. BEFORE REPEATING THE SAMPLE, THE USER FORCED A MANUAL SYSTEM CYCLE AND THE GLUCOSE CALIBRATION FAILED. THE COMMUNICATION INCLUDED A STATEMENT THAT IF THIS HAD BEEN A PATIENT OR A PROFICIENCY SAMPLE, THEY WOULD HAVE REPORTED OUT THE RESULT (MAYBE REPEATED IF A PATIENT BUT STILL REPORTED IT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ABL80 FLEX CO-OX ANALYZER PH, BLOODGAS, ELECTROLYTE ANALYSIS SYSTEM CHL SENDX MEDICAL, INC. 945-701 48368

    Patients

    Seq Age Sex Outcome Treatment
    1